Label: BACLOFEN tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 29, 2024

If you are a consumer or patient please visit this version.

  • DESCRIPTION
    Baclofen USP, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural ...
  • Clinical Pharmacology
    The precise mechanism of action of baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of ...
  • Indications and Usage
    Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus ...
  • CONTRAINDICATIONS
    Hypersensitivity to baclofen.
  • WARNINGS
    a.  Neonatal Withdrawal Symptoms:Withdrawal symptoms have been reported starting hours to days after delivery in neonates whose mothers were treated with oral baclofen throughout pregnancy ...
  • PRECAUTIONS
    Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness ...
  • ADVERSE REACTIONS
    The most common is transient drowsiness (10% to 63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the ...
  • OVERDOSAGE
    Signs and Symptoms:Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures. Treatment:In the alert patient, empty the stomach promptly ...
  • DOSAGE AND ADMINISTRATION
    The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 to 80 mg daily). The ...
  • HOW SUPPLIED
    Baclofen Tablets USP, 20 mg are white to off-white, round, flat-faced, beveled-edge scored tablet debossed with “B” above score line and “20” below score line on one side and plain on other side ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg
    Baclofen 20mg #30 ...
  • INGREDIENTS AND APPEARANCE
    Product Information